BEUDAMED
    FDA Recall Terminated

    Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet, ribbed balloon; catalog number 5578.

    Recall: Z-1349-04 · Initiated July 7, 2004

    Recall

    Recall Number
    Z-1349-04
    Event Number
    29475
    Firm
    Terumo Cardiovascular Systems Corp
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 7, 2004
    Posted
    August 17, 2004
    Terminated
    October 26, 2004
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet, ribbed balloon; catalog number 5578.

    Reason

    The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.

    Action

    The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.

    Distribution

    United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.